Kornimate/medical-research-clean huggingface dataset:
kangaroo mother care with plastic bag (trials 1a & 1b)

Conditions: Preterm Birth; Hypothermia, Newborn

Summary: the purpose of this study is to determine whether the combination of kangaroo mother care (kmc) as continuously as possible together with the use of a plastic bag in combination with routine world health organization (who) thermoregulation care reduces the incidence of moderate (32-36° c) or severe (\<32.0° c) hypothermia in preterm infants ≥ 32 to 36 6/7 weeks of gestational age (ga) when compared to kmc as continuously as possible together with routine who thermoregulation care.

the purpose of this study is to determine whether the combination of kangaroo mother care (kmc) as continuously as possible together with the use of a plastic bag in combination with routine world health organization (who) thermoregulation care (warm delivery rooms, immediate drying after birth, early and exclusive breastfeeding, postponement of bathing and weighing, and appropriate bundling) reduces the incidence of moderate hypothermia (32-36° c) or severe (\<32.0° c) in preterm infants ≥ 32 to 36 6/7 weeks of gestational age (ga) when compared to kmc as continuously as possible together with routine who thermoregulation care, as practiced. the investigators are proposing two trials, one protocol for infants 32-36 6/7 weeks (this one) and one for infants who are ≥37 weeks gestational age. this preterm infant trial will address the effectiveness of kmc in combination with plastic bags in decreasing hypothermia in preterm infants. the proposed trial will determine whether kmc with plastic bags prevents hypothermia in neonates born in a healthcare setting with limited resources where a high risk for hypothermia has been reported. any intervention that decreases morbidity during the neonatal period has the potential to impact health beyond the neonatal period,and one that is highly cost-effective and easy to use is more likely to be implemented in the developing world.

Eligibility criteria:
inclusion criteria: * estimated gestational age ≥32 0/7 - 36 6/7 weeks * delivery in the hospital exclusion criteria: * abdominal wall defect or myelomeningocele * major congenital anomalies * blistering skin disorder * clinically unstable mothers secondary to cardiovascular and pulmonary conditions * infants requiring respiratory support beyond 10 minutes after birth * infant requiring nicu admission * c/section * multiple gestation if the last delivering infant is not born within 10 minutes from the time of birth of the first infant

Keywords: infant newborn preterm hypothermia kangaroo plastic bag
wavstat® optical biopsy system to target esophageal biopsies

Conditions: Barrett's Esophagus

Summary: the purpose of this study is to demonstrate the clinical utility of the wavstat optical biopsy system as an adjunctive tool to improve the endoscopist's clinical sensitivity to identify dysplasia or cancer in the esophagus.

in the clinical portion of this prospective study, the algorithm developed in the preclinical evaluation will be blindly tested using the pathologists' assessment of the biopsies as a gold standard to determine the clinical sensitivity and specificity of the wavstat optical biopsy system to identify dysplastic or cancerous tissue in the esophagus. in addition, the endoscopist's unaided clinical sensitivity and specificity to identify dysplasia or cancerous tissue will also be determined by recording the endoscopist's visual assessment of whether the physical biopsy has dysplasia or cancer or does not have dysplasia or cancer prior to performing the biopsy the endoscopist's assessment will be correlated and compared with the pathologist's interpretation. the clinical utility of the wavstat system to improve the endoscopist's clinical sensitivity to identify dysplasia or cancer in the esophagus will be evaluated by testing the hypothesis that the sensitivity of a wavstat-assisted endoscopic examination improves that of standard endoscopy alone.

Eligibility criteria:
inclusion criteria: * the patient is between 18 and 80 years of age. * the patient is willing to sign an informed consent form. * the patient is a candidate for endoscopic examination * female patients of child-bearing age, uncertain of pregnancy status, must have a negative pregnancy test. exclusion criteria: * the patient has congenital deformities, which preclude a physical biopsy procedure during endoscopy. * the patient is pregnant or nursing by admission. * the patient has other contraindications for physical biopsy.

Keywords: barrett's dysplasia esophageal cancer patients
use of somatropin in turner syndrome

Conditions: Genetic Disorder; Turner Syndrome

Summary: this trial is conducted in europe. the aim of this trial is to study the dose-response relationship and effect of somatropin (norditropin®) on final height in girls with turner syndrome.


Eligibility criteria:
inclusion criteria: * turner syndrome * not previously treated with growth hormone or androgen * well-documented height over the previous 12 months * informed consent of parents (and child if appropriate) exclusion criteria: * growth hormone (gh) deficiency based on a gh stimulation test
delayed umbilical cord clamping in infants less than 32 weeks

Conditions: Premature Birth

Summary: the overall objective of the present study is to examine the effects of delayed umbilical cord clamping in preterm infants on neonatal outcomes using a prospective randomized controlled trial comparing immediate cord clamping (standard at present) with delayed cord clamping. our specific aim is to determine if a 30 to 45 second delay in umbilical cord clamping improves neonatal outcome as assessed by a composite of intraventricular hemorrhage and late onset sepsis in preterm infants born between 24 and 32 weeks gestation. secondary outcomes to be examined include improvements in the following: 1) lung function as assessed by oxygen dependency at 36 weeks corrected gestational age (cga), 2) cardiovascular function as assessed by the need for volume expansion, inotropes, or clinically suspected pda requiring intervention prior to discharge home, and 3) anemia as assessed by initial hemoglobin, need for transfusion during stay in the nicu, and number of transfusions.


Eligibility criteria:
inclusion criteria: * women in labour or with a plan for delivery at a gestational age between 24 0/7 to 32 0/7 weeks gestation. * singleton pregnancy (note: if pregnancy was a multiple gestation but demised occurred prior to 13 weeks, these patients can be included in study). exclusion criteria: * moderate to life threatening fetal anomalies * multiple live gestations at birth (e.g. twins, triplets, etc) * intrauterine fetal demise * previous participation * stem cell collection

Keywords: umbilical cord clamping preterm infants randomized controlled trial for women giving birth to singleton infants 32 weeks gestational age or less
effectiveness of continence promotion interventions among community-dwelling older women

Conditions: Urinary Incontinence

Summary: urinary incontinence is a common and bothersome condition that remains frequently untreated among senior women. the aim of this trial is to compare the effectiveness of two community-based continence promotion interventions aimed at improving rates of self-care and/or professional health-care seeking in older women with urinary incontinence. the main hypothesis posits that participation in a constructivist interactive workshop combined with use of an evidence-based self-management tool will yield rates of improvement in incontinence frequency and reduce the cost of pad use by 20% compared to either intervention alone, which individually are expected to yield minimal effect sizes of at least 0.3 compared to a sham intervention.

the research design is a 2x2 factorial open-label cluster randomised controlled trial. the cluster (unit of randomization) is at the level of each local community senior's group, from whence participants will be recruited. incontinent community-dwelling older women aged 60 years and older who have not sought care for their urinary symptoms in the last two years, but who experience incontinence at least twice weekly will be recruited through local community organizations. eligible participants from each local community centre will be randomly assigned as a group to one of four interventions. the first intervention is participation in an interactive constructivist continence workshop. the second intervention involves receipt of an evidence-based self-management tool for incontinence. the third group will receive both interventions. the fourth group will act as the control group: they will simply be asked about their urinary symptoms and given a general talk on women's health. at the end of the study, the control group will be offered the self-management tool.

Eligibility criteria:
inclusion criteria: * female * 60 years or older * urinary incontinence twice weekly * women who have not sought medical advice for incontinence symptoms in the last 2 years. * fluent in english exclusion criteria: * women who have received treatment for their urinary incontinence within the past two years from a health care provider with expertise in urinary incontinence management (i.e. nurse practitioners/physicians/surgeons who have a clinical practice that focuses on treating urinary incontinence). * women started on medications for urinary incontinence (i.e. antimuscarinic medication) within the 6 months prior to enrolment. * women with a history of a neurological condition (e.g. multiple sclerosis and spinal cord injury) because they require further investigation. women identified to have these historical findings will be advised to speak to their physician immediately about their incontinence and the possible need for investigation. * women who do not consent to participate.

Keywords: urinary incontinence, self-management, cost, self-efficacy, continence promotion
rhythm and depression

Conditions: Depression

Summary: the study aims to characterize the rhythmic parameters of unipolar depressed patients that are associated with the response to antidepressants after 6 weeks of treatment.

patients are included at the time of their hospitalization in the psychiatry unit. they perform rhythmic parameters recording within 48hours after the initiation of the antidepressant treatment. an evaluation of the evaluation of the severity of depression symptoms is performed at 2, 4 and 6 weeks after the initiation of the antidepressant treatment. a correlation analysis will be performed with rhythmic parameters and the response to the antidepressant treatment.

Eligibility criteria:
inclusion criteria: * current unipolar major depressive disorder according to the diagnostic ans statistics manual (dsm)v * madrs score \> 25 exclusion criteria: * other psychiatric disorder * current treatment with thymoregulating agent * clozapine treatment * heart disease that could alter heart rate characteristics * disease associated with fever * shift work within 3 months before inclusion * transmeridian travel in the preceding month * guardianship

Keywords: rhythm depression antidepressant treatment
validation and evaluation of the icf rehabilitation set

Conditions: Chronic Disease

Summary: rehabilitation is considered a key health strategy in the 21st century. the aim of rehabilitation is to optimize the functioning of patients. the international classification of functioning, disability and health (icf) is a framework for describing and organizing information on functioning and disability. therefore, the aim of the study is to validate and evaluate the application of the icf rehabilitation set in polish clinical practice.

according to the world health organization (who) rehabilitation is defined as "a set of interventions designed to optimize functioning and reduce disability in individuals with health conditions in interaction with their environment." rehabilitation is considered a key health strategy in the 21st century. demographic and epidemiological trends indicate that human functioning is one of the most important indicators of population health, apart from morbidity and mortality. thus, it suggests that the main focus of healthcare will be on the real health needs generated by long-term treatment of chronic diseases, including comprehensive enhancement and intensification of rehabilitation. the aim of rehabilitation is to optimize functioning of patients. who indicates international classifications and terminologies including the international statistical classification of diseases and related health problems (icd) and the international classification of functioning, disability and health (icf) as the global standards for collecting data regarding health, clinical documentation and statistical data aggregation3. icf and icd provide health information in relation to diagnosis (icd) as well as functioning and disability (icf). the icf is based on a holistic biopsychosocial disability model that allows for a comprehensive and wide approach to the problems of an individual related to functioning in his/her living environment. a polish version of the icf rehabilitation set has been developed, which contains 29 categories and is proposed as framework for harmonizing information on the functioning and disability of people participating in the rehabilitation process. therefore, the aim of the study is to validate and assess the use of the icf rehabilitation set in polish clinical practice.

Eligibility criteria:
inclusion criteria: * presence of chronic diseases, including: neurological, cardiological, pulmonary and musculoskeletal problems. * cognitive state, enabling to answer questions reliably and accurately, minimum 6 points on the amts scale * adults participating in the rehabilitation process * consent to participate in the study. exclusion criteria: * previous surgeries, with surgical intervention. * fractures. * severe systemic diseases that prevent the examination, e.g. acute neoplastic disease, exacerbation of chronic diseases, infections.

Keywords: disability rehabilitation icf
89zr-bevacizumab pet/ct imaging in nf2 patients

Conditions: Neurofibromatosis 2

Summary: bevacizumab can be an effective treatment for individuals with nf2 and improve different nerve functions (like hearing, tinnitus or balance problems) and the quality of life of nf2 patients. however, bevacizumab is not effective in all patients or all tumors, at the cost of moderate toxicity and considerable financial burden. therefore, this observational study will validate an imaging biomarker method to predict bevacizumab efficacy in order to avoid adverse effects and high costs in non-responders to bevacizumab treatment. patients will undergo standard-of-care treatment with the sole addition of a pre-treatment 89zr-bevacizumab pet/ct-scan. per standard-of-care bevacizumab therapy is administered every three weeks for six months. to monitor treatment effect, follow-up is performed at 3-month intervals.


Eligibility criteria:
inclusion criteria: * patients aged 18 years or older * confirmed diagnosis of nf2 by revised manchester criteria * provided written informed consent * patients must have measurable disease, defined as at least one vs \> 0.4 ml (on volumetric analysis) that can be accurately measured by contrast-enhanced t1-weighted cranial mri scan. * eligible and planned for bevacizumab treatment exclusion criteria: * patients with a contra-indication for pet and mri, such as pregnancy and metal elements. * patients with a known allergy to substances used in this study * concurrent treatment with everolimus

Keywords: neurofibromatosis 2 nf2-related schwannomatosis vestibular schwannoma bevacizumab 89zr-bevacizumab pet/ct imaging hearing
detection of covid-19 using breath analysis - validation study

Conditions: Covid19

Summary: detection of the 2019 novel coronavirus (sars-cov-2) using breath analysis- validation study

a diagnostic prospective single-site study, with no anticipated risks or constraints. primary objective- to validate the value of a set of breath voc biomarkers that enable us to distinguish between coronavirus (sars-cov-2) carriers and sars-cov-2-negative in comparison to the gold-standard testing methodology.

Eligibility criteria:
inclusion criteria: * age 6 to 75 years at the time of consent * capable of understanding written and/or spoken language * able to provide informed consent * was not treated with anti-viral drugs exclusion criteria: * age under 6 years old * under guardianship or deprived of liberty * pregnant or lactating woman
novel technique of analgesia following open liver resection

Conditions: Postoperative Pain; Liver Resection

Summary: abdominal wall incisions used for liver surgeries are associated with significant postoperative pain and disability. epidural analgesia is often contraindicated in these patients due to common bleeding problems. furthermore, drugs such as acetaminophen and opioids are often inadequate and can lead to detrimental side-effects. abdominal wall (aw) catheters can be placed during surgical closure along the incision line and can be used to administer local anesthetics for postoperative pain. the study is a multi-centre, double-blind, randomized controlled trial involving 120 patients undergoing elective liver surgery. patients will be randomly assigned to aw catheter group treated with drug or control treated with saline. treatment group will receive aw catheters with ropivacaine plus standard patient controlled analgesia (pca). control group will obtain aw with normal saline and no local anesthetics and pca. patients are followed for 6 months post-operatively for pain scores, side-effects, chronic pain and complications.


Eligibility criteria:
inclusion criteria: * \>18 years age * undergoing liver resection using a subcostal incision exclusion criteria: * patients unable to comprehend instructions, consent, or co-operate with pain assessment (including psychiatric disorders, pre-operative sedation, coma) * allergy to any study medications * patient not able to be extubated postoperatively for any clinical reason * laparoscopic surgery * co-existing epidural or intrathecal analgesia * chronic pain disorders or on long-term opioid use * history of substance or alcohol abuse * transplant donor liver resections * patients with liver cirrhosis

Keywords: postoperative pain liver resection medial open transversus abdominis plane catheter
long-term effect of the mother infant transaction program (mitp)

Conditions: Premature Births

Summary: the purpose of this study is to investigate if a cost and time effective intervention in a previous rct for preterm infants and their parents can reduce the parents experience of concern and stress, and improve the childrens development in various aspects at three years of corrected age. hypothesis 1: the preterm born children of parents who were enrolled in the earlier rct have a higher developmental level then preterm children of parents who received the usual treatment. hypothesis 2: parents who who were enrolled in the earlier rct will have a lower level of stress and concern then parents who received treatment as usual.

a previous rct by ravn (nct00245843) investigated if the mitp could sensitize the mothers toward the babies signals and thereby increase the quality of joint attention. the study followed the children for 1 year. this study is a follow-up to the above mentioned rct. it investigates whether the effect of the rct is present at three years corrected age. the research questions are: 1. can a psychoeducative program like the mitp influence the childrens' development in various aspects? 2. how did the mitp influence the parents experience of concern and stress three years later? 3. were there any differences by the groups? a) preterm intervention group b)preterm control group c) full term control group the questionnaires to be used in this observational study are: ages and stages

Eligibility criteria:
inclusion criteria: * all parents of children who participated in ravn's rct and who said yes to be asked for participation in an eventually later study will be asked.

Keywords: premature babies social interaction psychoeducative intervention mother infant transaction program three years follow-up late preterm cognitive development social development emotional development motor development children born preterm and their parents
standard and delayed fdg pet/ct after chemoradiation therapy in assessing patients with metastatic head and neck squamous cell cancer

Conditions: Metastatic Head and Neck Squamous Cell Carcinoma; Metastatic Malignant Neoplasm in the Spine

Summary: this trial studies how well standard and delayed fludeoxyglucose f-18 (fdg)-positron emission tomography (pet)/computed tomography (ct) given after standard radiation and chemotherapy works in assessing patients with head and neck squamous cell cancer that has spread to other places in the body. diagnostic procedures, such as pet/ct, use radioactive material, such as fludeoxyglucose f-18, to find and diagnose head and neck tumors and may help to find out how far the disease has spread.

primary objective: i. to assess the optimal imaging time using fdg positron emission tomography (pet) with comparison between a standard of care 1-hour scan (early) and the research scan of 3-hours scan (delayed) post radiotracer administration that maximizes separation of activity between lesion and non-lesional parenchyma (measured as lesion/background \[l/b\] ratio) in patients with head and neck primary squamous cell carcinoma following chemoradiation treatment. outline: patients receive fludeoxyglucose f-18 intravenously (iv) over 1 minute and undergo pet/ct at 70 and 180 minutes after injection at 12-14 weeks following standard chemoradiation (crt) completion. after completion of study, patients are followed up at 30 days and then periodically for up to 6 months.

Eligibility criteria:
inclusion criteria: * adult with computed tomography (ct) or fludeoxyglucose f-18 (fdg) positron emission tomography (pet) findings of cervical nodal metastasis from a head and neck primary squamous cell carcinoma treated with definitive chemoradiation exclusion criteria: * children * no evidence of cervical nodal metastasis * active infection of the head and neck * known allergy to fdg, iodine or gadolinium-based contrast agents * blood glucose (\> 250 mg/dl) * pregnant women